Compositions and methods for the treatment of cellulite

ABSTRACT

Described herein are methods and formulations for treating, inhibiting, or ameliorating cellulite. Aspects described herein relate to formulations including a saline solution, reactive oxygen species, a rheology agent, an emollient, and a pH modifier and methods of using these formulations for treating, ameliorating, or inhibiting cellulite.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/173,917, filed Oct. 29, 2018, which claims priority to U.S. Prov.App. No. 62/609,899, filed Dec. 22, 2017, entitled “COMPOSITIONS ANDMETHODS FOR THE TREATMENT OF CELLULITE” which is incorporated byreference herein in its entirety.

FIELD

The present disclosure relates to methods and compositions for treating,reducing, inhibiting, or ameliorating cellulite or the appearance ofcellulite. Specifically, the present disclosure relates to formulationsincluding a saline solution, a reactive oxygen species, a rheologyagent, an emollient, and a pH modifying agent for treating cellulite,and methods of using the cellulite treatment formulations to treat,prevent, reduce, or ameliorate cellulite or an appearance of cellulite.

BACKGROUND

Cellulite is a skin condition often described as an “orange peel,”“mattress,” “cottage cheese,” or “dimpling” appearance on the thighs,buttocks and sometimes lower abdomen and upper arms of otherwise healthywomen. Cellulite is caused by small protrusions of fat called papillaeadiposae into the dermis. This structural alteration of subcutaneous fatprotruding (or herniating) into the dermis gives skin the bumpyappearance referred to as cellulite. Individuals with cellulite andhigher BMIs have a weaker, less dense connective tissue structure,leading to increased extrusion of adipose tissue lobules through thehypodermis.

SUMMARY

The present disclosure is directed to compositions and methods fortreating, preventing, reducing, or ameliorating cellulite or theappearance of cellulite.

Some embodiments provided herein relate to a method of reducing anappearance of cellulite in a subject in need thereof. In someembodiments, the method includes identifying a region of a body havingcellulite. In some embodiments, the method further includes topicallyapplying to the region of the body a composition for treating cellulite.In some embodiments, the composition includes a saline solution, areactive oxygen species, a rheology agent, an emollient, and a pHmodifier. In some embodiments, the method reduces the appearance ofcellulite. In some embodiments, the method further includes massagingthe composition into the region of the body having cellulite untilabsorbed. In some embodiments, the composition is administered daily tothe region of the body having cellulite.

In some embodiments, reducing the appearance of cellulite includesincreasing skin elasticity. In some embodiments, reducing the appearanceof cellulite includes reducing subcutaneous fat nodularity. In someembodiments, reducing the appearance of cellulite includes increasinglipolysis in adipocytes.

In some embodiments, the composition includes salt in an amount of about0.01% to about 1% w/v; hypochlorite in an amount of about 50 to about100 ppm; sodium magnesium silicate in an amount of about 0.5% to about10% w/v; dimethicone in an amount of about 0.5% to about 10% w/v; andsodium phosphate monobasic in an amount of about 0.05% to about 5% w/v.In some embodiments, the salt is purified or refined salt, such as tablesalt. In some embodiments, the salt is raw, unprocessed salt. In someembodiments, the salt is Himalayan sea salt.

Some embodiments provided herein relate to a cellulite treatmentformulation. In some embodiments, the formulation includes a salinesolution, a reactive oxygen species, a rheology agent, an emollient, anda pH modifier.

In some embodiments, the saline solution includes salt in an amount ofabout 0.01% to about 1% w/v, such as 0.01%, 0.02%, 0.03%, 0.04%, 0.05%,0.06%, 0.07%, 0.08% 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%,0.8%, 0.9%, or 1% or an amount within a range defined by any two of theaforementioned values. In some embodiments, the salt is present in anamount of about 0.05% w/v. In some embodiments, the salt is present inan amount of about 0.05% w/w. In some embodiments, the salt is purifiedor refined salt, such as table salt. In some embodiments, the salt israw, unprocessed salt. In some embodiments, the salt is Himalayan seasalt.

In some embodiments, the reactive oxygen species is hypochlorite. Insome embodiments, the reactive oxygen species is present in an amount ofabout 25 to about 100 ppm. In some embodiments, the reactive oxygenspecies is present in an amount of about 72 ppm. In some embodiments,the reactive oxygen species is present in an amount of about 0.16% w/w.

In some embodiments, the rheology agent is a metal silicate. In someembodiments, the metal silicate is sodium magnesium silicate. In someembodiments, the rheology agent is present in an amount of about 0.5% toabout 10% w/v. In some embodiments, the rheology agent is present in anamount of about 3.25% w/v. In some embodiments, the rheology agent ispresent in an amount of about 3.14% w/w.

In some embodiments, the emollient is a silicone polymer. In someembodiments, the silicone polymer is dimethicone, cyclomethicone, or ablend thereof. In some embodiments, the emollient is present in anamount of about 0.5% to about 10% w/v. In some embodiments, theemollient is present in an amount of about 5% w/v. In some embodiments,the emollient is present in an amount of about 0.93% w/w.

In some embodiments, the pH modifier is sodium phosphate monobasic. Insome embodiments, the pH modifier is present in an amount of about 0.05%to about 5% w/v. In some embodiments, the pH modifier is present in anamount of about 0.3% w/v. In some embodiments, the pH modifier ispresent in an amount of about 0.19% w/w.

In some embodiments, the formulation is in the form of a cream, foam,gel, serum, lotion, mousse, ointment, paste, serum, solution, spray,stick, or suspension.

Some embodiments provided herein relate to a cellulite treatmentformulation. In some embodiments, the formulation includes salt in anamount of about 0.05% w/v, hypochlorite in an amount of about 72 ppm,sodium magnesium silicate in an amount of about 3.25%, dimethicone in anamount of about 5%, and sodium phosphate monobasic in an amount of about0.3% w/v.

Some embodiments provided herein relate to a cellulite treatmentformulation. In some embodiments, the formulation includes salt in anamount of about 0.05% w/w, a reactive oxygen species in an amount ofabout 0.16% w/w, a metal silicate in an amount of about 3.14% w/w, asilicone polymer in an amount of about 0.93% w/w, and a pH modifier inan amount of about 0.19% w/w.

DETAILED DESCRIPTION

Embodiments provided herein related to compositions that treat, reduce,inhibit, or ameliorate cellulite or the appearance of cellulite. In someembodiments, the composition includes a saline solution, a reactiveoxygen species, a rheology agent, an emollient, and a pH modifier. Alsoprovided are uses of the compositions in the treatment, reduction,inhibition, or amelioration of cellulite or the appearance of cellulite.The compositions may be provided to a subject for topical application toskin or a region of a body having an appearance of cellulite.

It will be readily understood that the aspects of the presentdisclosure, as generally described herein, can be arranged, substituted,combined, separated, and designed in a wide variety of differentconfigurations, all of which are explicitly contemplated herein.

Unless defined otherwise, technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present disclosure belongs. All patents,applications, published applications and other publications referencedherein are expressly incorporated by reference in their entiretiesunless stated otherwise. For purposes of the present disclosure, thefollowing terms are defined below.

By “about” is meant a quantity, level, value, number, frequency,percentage, dimension, size, amount, weight or length that varies by asmuch as 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% to a referencequantity, level, value, number, frequency, percentage, dimension, size,amount, weight or length. When a value is preceded by the term about,the component is not intended to be limited strictly to that value, butit is intended to include amounts that vary from the value.

Throughout this specification, unless the context requires otherwise,the words “comprise,” “comprises,” and “comprising” will be understoodto imply the inclusion of a stated step or element or group of steps orelements but not the exclusion of any other step or element or group ofsteps or elements.

As used herein, a “subject” or a “patient” refers to an animal that isthe object of treatment, observation or experiment. “Animal” comprisescold- and warm-blooded vertebrates and invertebrates such as fish,shellfish, reptiles and, in particular, mammals. “Mammal” comprises,without limitation, mice, rats, rabbits, guinea pigs, dogs, cats, sheep,goats, cows, horses, primates, such as monkeys, chimpanzees, and apes,and, in particular, humans. In some alternatives, the subject is human.

Some embodiments disclosed herein relate to selecting a subject orpatient in need. In some embodiments, a patient is selected who is inneed of treatment, amelioration, inhibition, progression, prophylaxis,or improvement in disease symptoms or who is in need of curativetherapy. In some embodiments, a patient is selected who has cellulite orwho has the appearance of cellulite. Such identification or selection ofsaid subjects or patients in need can be made through clinical and/ordiagnostic evaluation. In some embodiments, a subject is selected whodoes not have the appearance of cellulite, but who wishes to prevent theappearance of cellulite.

As used herein, the term “treatment” refers to an intervention made inresponse to a disease, disorder, or physiological condition manifestedby a subject, particularly a subject having cellulite or having anappearance of cellulite. The terms treating, treatment, therapeutic, ortherapy do not necessarily mean total cure or abolition of the diseaseor condition. The aim of treatment may include, but is not limited to,one or more of the prophylaxis of cellulite, alleviation or preventionof symptoms, slowing or stopping the progression or worsening ofcellulite, curative treatment of cellulite, or the remission ofcellulite. In some embodiments, treatment refers to both treatment ofcellulite as well as treatment of the physical manifestation orappearance of cellulite. For example, in some embodiments, treatmentsreduce, alleviate, ameliorate, or eradicate the symptom(s) of thedisease and/or provide curative therapy of the disease. In someembodiments, treatment includes administration to a subject that doesnot have any manifestation of cellulite, but the formulations providedherein are provided for the purpose of preventing the development oronset of cellulite.

The term “therapeutically effective amount” is used to indicate anamount of a composition that elicits the biological or medicinalresponse indicated. For example, a therapeutically effective amount ofcomposition can be the amount needed to prevent, alleviate, orameliorate cellulite or the appearance of cellulite. Determination of atherapeutically effective amount is within the capability of thoseskilled in the art, in view of the disclosure provided herein. Thetherapeutically effective amount of the composition disclosed hereinrequired as a dose will depend on the route of administration, the typeof animal, including human, being treated, and the physicalcharacteristics of the specific animal under consideration. The dose canbe tailored to achieve a desired effect, but will depend on such factorsas weight, diet, concurrent medication and other factors which thoseskilled in the medical arts will recognize.

As used herein, the term “cellulite” is synonymous with lipodystrophy,an alteration of the appearance of the skin surface resulting from theprotrusion of adipose lobules through unstretchable conjunctive tissue.This condition is distinct from obesity and may be present on theabdomen, thighs and buttocks, and especially the thighs and buttocks.Cellulite is also known as adiposis edematosa, dermopanniculosisdeformans, status protrusus cutis, gynoid lipodystrophy, or orange peelsyndrome.

Some embodiments disclosed herein relate to identifying a region of abody in need of treatment, or skin in need of treatment. As used herein,the term “skin in need of skin cellulite treatment” refers generally toskin, particularly skin of the abdomen, pelvic region, buttocks, thighs,or lower limbs that exhibits a padded and orange-peel appearancegenerally from the protrusion of adipose lobules through unstretchableconjunctive tissue. According to certain embodiments, skin in need ofcellulite treatment includes skin having clinical “Grade 2” cellulite(after skin compression or after muscular contraction there is pallor,decreased temperature and decreased elasticity; no relief alterations atrest; histopathologically, hyperplasia and hypertrophy of theperiadipocyte and pericapillary argentaffin fibril framework occursalong with capillary dilatation, microhaemorrhages and increasedthickness of the capillary basement membrane) or higher, as described inA. Beatris et al. Cellulite: A Review Journal of European Academy ofDermatology and Venerology 2000, 14, 251-262. In some embodiments, aregion of a body is identified that does not have manifestations ofcellulite, but the formulation is administered for the purpose ofprevention the development or onset of cellulite at that region of thebody.

Some embodiments provided herein relate to cellulite treatmentformulations that include a saline solution, a reactive oxygen species,a rheology agent, an emollient, and a pH modifier. In some embodiments,the cellulite treatment formulation is administered topically to skinhaving or manifesting cellulite. As used herein, the term “cellulitetreatment formulation” refers to embodiments of the formulation asdescribed herein that is used for the treatment, prevention,amelioration, or reduction of cellulite.

In some embodiments, the cellulite treatment formulation is effective asa stand-alone treatment for cellulite, and as such, is administeredalone without other treatments, therapies, or agents for treatingcellulite. In some embodiments, the cellulite treatment formulation isadministered in combination with a cellulite therapy, including lasertherapy, shockwave therapy, ultrasound therapy, cellulite creams,scrubs, brushes, massage, or mesotherapy.

As used herein, the term “saline solution” refers to a solution having aquantity of salt. In some embodiments, the saline solution includes apurified or refined salt. In some embodiments, the saline solutionincludes a raw or unprocessed salt. In some embodiments, the salt ishalite, table salt, common salt, curing salt, flake salt, Epsom salt,sea salt, Alaea salt (or Hawaiian sea salt), Alpenbergkern salt,Anglesey Sea salt, Celtic sea salt, Dead Sea salt, Himalayan sea salt(including Himalayan pink sea salt), Kalahari salt, Maras salt, MurrayRiver salt flakes, Namibian salt pearls, Persian blue fine salt, Polishmine salt, primordial sea salts, Sal de Tavira, Sale Marino di Trapani,Sel de Guérande, South African Sea salt, Utah salt, black lava salt,brine, rock salt, red rock salt, fleur de sel, or kosher salt. The saltpresent in the saline solution can include a number of elements,including actinium, aluminum, antimony, arsenic, astatine, barium,beryllium, bismuth, boron, bromine, cadmium, calcium, carbon, cerium,cesium, chlorine, chromium, cobalt, copper, dysprosium, erbium,europium, francium, fluorine, gadolinium, gallium, germanium, gold,hafnium, holmium, hydrogen, iodine, indium, iridium, iron, lanthanum,lead, lithium, lutetium, magnesium, manganese, mercury, molybdenum,neptunium, neodymium, nickel, niobium, nitrogen, osmium, oxygen,palladium, phosphorus, platinum, plutonium, polonium, potassium,praseodymium, promethium, protactinium, radium, rhenium, rhodium,rubidium, ruthenium, samarium, scandium, selenium, silicon, silver,sodium, strontium, sulfur, tantalum, technetium, tellurium, terbium,thallium, thorium, thulium, tin, titanium, uranium, vanadium, ytterbium,zinc, or zirconium. In some embodiments, the element present in the saltcan be present in an amount of less than 0.001 ppm to an amount ofgreater than 400,000 ppm. In some embodiments, the saline solutionincludes salt in an amount of 0.001, 0.005, 0.01, 0.02, 0.03, 0.04,0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,0.9, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5, 6, 7, 8, 9, 10, 11, 12,13, 14, or 15% (w/v), or an amount within a ranged defined by any two ofthe aforementioned values. In some embodiments, the saline solutionincludes salt in an amount of 0.05%.

As used herein, the term “reactive oxygen species (ROS)” refers tochemically reactive molecules containing oxygen. Examples include ozone,peroxides, active chlorines, active oxygens, superoxides, activehydrogens, hydroxyl radical, and singlet oxygen. ROS are formed as anatural byproduct of the normal metabolism of oxygen and have importantroles in cell signaling and homeostasis. ROS can include, but are notlimited to superoxides (O₂*⁻, HO₂*), hypochlorites (OCl⁻, HOCl, NaClO),hypochlorates (HClO₂, ClO₂, HClO₃, HClO₄), oxygen derivatives (O₂, O₃,O₄*⁻, O), hydrogen derivatives (H₂, H⁻), hydrogen peroxide (H₂O₂),hydroxyl free radical (OH*), ionic compounds (Na⁺, Cl⁻, H⁺, OH⁻, NaCl,HCl, NaOH), chlorine (Cl₂), water clusters (n*H₂O-induced dipolar layersaround ions), and combinations thereof. Some ROS can be electronacceptors and some can be electron donors. In some embodiments, areactive oxygen species is a hypochlorite.

“Hypochlorous acid”, as used herein, refers to a weak acid having thechemical formula HClO. Hypochlorous acid is also known as chloric (I)acid, chloranol, or hydroxidochlorine. Hypochlorite includes ions ofhypochlorous acid (for example, OM. Salts of hypochlorite are alsoreferred to herein and can include sodium hypochlorite (NaClO), calciumhypochlorite (Ca(ClO)₂), or potassium hypochlorite (KClO). Hypochlorite,or acids and salts thereof, may be present in the cellulite treatmentformulations described herein in an amount of 0.001%, 0.005%, 0.01%,0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%,0.3%, 0.4%, 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, or greaterw/v %, or within a range defined by any two of the aforementionedamounts. In some embodiments, the w/v % of hypochlorite or an acid orsalt thereof is 0.072% w/v. In some embodiments, the hypochlorite, orsalt or acid thereof, is added directly to a cellulite treatmentformulation. In some embodiments, the hypochlorite, or acid or saltthereof, is generated in the cellulite treatment formulation byelectrolysis. In some embodiments, the final amount of hypochlorous acidis less than, greater than, or equal to about 10, 15, 20, 25, 30, 35,40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200,300 ppm or within a range defined by any two of the aforementionedamounts. In some embodiments, the amount of hypochlorous acid in thecellulite treatment formulation is between about 50 to about 100 ppm. Insome embodiments, the amount of hypochlorous acid in the cellulitetreatment formulation is about 72 ppm.

As used herein, the term “rheology agent” refers to a substance thatmodulates the viscosity of a cellulite treatment formulation, withoutmodifying other properties of the cellulite treatment formulation. Insome embodiments, the rheology agent acts as a thickener by increasingthe viscosity of the cellulite treatment formulation. In someembodiments, the rheology agent can include a metal silicate. In someembodiments, the rheology agent is sodium magnesium silicate, a silicateof sodium and magnesium. In some embodiments, sodium magnesium silicateis a synthetic silicate clay, having magnesium and sodium silicate. Insome embodiments, a rheology agent is used as a binder and bulking agentin cosmetics and personal care products, in part because of its abilityto absorb water. Sodium magnesium silicate is effective in slowing thedecomposition of formulas, and can prevent premature darkening ofcompositions and prevent premature development of a foul odor, therebyimproving the shelf life of cosmetic compositions. In some embodiments,the sodium magnesium silicate is Laponite, including for example,Laponite XL21™, Laponite RD™, Laponite RDS™, Laponite S482™, LaponiteSL25™, Laponite EP™, Laponite JS™, Laponite XLS™, Laponite D™, orLaponite XLG™. The rheology agent may be used in the cellulite treatmentformulation in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%,2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v %, orin an amount within any two of the aforementioned values or between arange defined by these values. In some embodiments, the amount ofrheology agent is about 3% w/v.

As used herein, an “emollient” refers to a compound that soothes theskin. In some embodiments, an emollient is a moisturizer, a cream, alotion, an oil, a rub, a salve, an unguent, or a balm. In someembodiments, the emollient is a silicone polymer. In some embodiments,the silicone polymer is dimethicone, which is also known aspolydimethylsiloxane (PDMS), dimethylpolysiloxane, E900, or polymerizedsiloxane and has the chemical formula of CH₃[Si(CH₃)₂O]_(n)Si(CH₃)₃where n is the number of repeating monomer [Si(CH₃)₂] units. Siliconepolymers also include cyclomethicone, which is a cyclic siloxane. Insome embodiments, the silicone polymer used in the cellulite treatmentformulation is a blend of dimethicone and cyclomethicone. In someembodiments, the silicone polymer is dimethicone satin, a mixture of lowand high molecular weight linear silicones. In some embodiments, thesilicone polymer is amodimethicone, cyclo-dimethicone, cyclomethicone,dimethicone 500, dimethicone satin, iso-dimethicone copolymer, or blendsthereof. In some embodiments, a silicone polymer acts as a moisturizer,a slip agent, or a lubricant. The emollient may be present in thecellulite treatment formulation in an amount of about 0.5%, 1%, 5%, 10%,15%, 20%, 30%, 40%, 50%, or greater w/v %, or in an amount within anytwo of the aforementioned values or between a range defined by thesevalues. In some embodiments, the amount of silicone polymer is about 5%w/v.

As used herein, the term “pH modifier” refers to an acid, base, or agentthat may be used to change or stabilize the pH of the cellulitetreatment formulation. A pH modifier may include an agent for modifyingthe pH of a solution or formulation, such as an acid or a base,including, for example, mineral acids such as hydrochloric acid,phosphoric acid and sulphuric acid, organic acids such as benzoic acid,citric acid, lactic acid, maleic acid, malic acid, tartaric acid, adipicacid, gluconic acid and their salts and bases such as sodium hydroxideand potassium hydroxide. In some embodiments, a pH modifier may includean agent for stabilizing the pH of a solution or formulation at adesired pH, including for example, a buffer such as a sodium acetate,acetate, citrate, or phosphate buffer. In some embodiments, the pHmodifier is sodium phosphate monobasic. In some embodiments, the pHmodifier is present in an amount of about 0.001%, 0.005%, 0.01%, 0.02%,0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%,0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%,or 15% w/v, or an amount within a range defined by any two of theaforementioned values. In some embodiments, the pH modifier is presentin an amount of about 0.3% w/v. As used herein, the pH of thecomposition is the numerical scale to specify the acidity or basicity ofthe cellulite treatment formulation. In some embodiments, the pH of thecellulite treatment formulation is about 5.0 to about 8.5, such as 5.0,5.5, 6.0, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6,7.7, 7.8, 7.9, 8.0, or 8.5, or within a ranged defined by any two of theaforementioned values. In some embodiments, the pH of the cellulitetreatment formulation is in a range from about 6.0 to about 7.8.

In some embodiments, the cellulite treatment formulations describedherein have osmolality measurement values of about 0.5 to 200 mOsm/kg,such as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,8.5, 9, 9.5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90,100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 mOsm/kg, orwithin a range defined by any two of the aforementioned values. In someembodiments, the cellulite treatment formulations have osmolalitymeasurement values of about 3 to 5 mOsm/kg. In some embodiments, thecellulite treatment formulations have osmolality measurement values ofabout 113 mOsm/kg.

The cellulite treatment formulations described herein may furtherinclude an additive known in the art. In some embodiments, the additiveincludes a compound that improves the formulation for the mode ofadministration. In some embodiments, the additive improves the efficacyof the formulation. In some embodiments, the additive improves the shelflife of the formulation. In some embodiments, the additive is includedfor aesthetic purposes to improve the appearance, texture, scent, orfeel of the formulation. Exemplary additives for including in acellulite treatment formulation include moisturizers, humectants,pigments, dyes, pearlescent compounds, nacreous pigments, bismuthoxychloride coated mica, titanium dioxide coated mica, colorants,fragrances, biocides, preservatives, lipolytic agent, diuretics,xanthines (such as caffeine, theophylline, and aminophylline), alphahydroxy acids, antioxidants, lymphatic drainage agent, antiperspirantagents, exfoliants, hormones, anticellulitic, enzymes, medicinalcompounds, vitamins, minerals, electrolytes, alcohols, polyols,polypropylene glycol, anti-adipogenesis agents, retinoids, retinol,polyisobutene, polyoxyethylene, behenic acid, behenyl, sugar-alcohols,absorbing agents for ultraviolet radiation, botanical extracts,surfactants, silicone oils, organic oils, waxes, alkaline or acidic orbuffering agents, film formers, thickening agents, hyaluronic acid,fumed silica, hydrated silica, talc, kaolin, starch, modified starch,mica, nylon, clay, bentonite, organo-modified clays, and combinationsthereof.

Examples of exfoliants include, but are not limited to, alpha-hydroxyacids such as lactic acid, glycolic acid, malic acid, tartaric acid,citric acid, or any combination of any of the foregoing, beta-hydroxyacids such as salicylic acid, polyhydroxy acids such as lactobionic acidand gluconic acid, and mechanical exfoliation such as microdermabrasion.

The cellulite treatment formulations provided herein may be prepared,packaged, or sold in cellulite treatment formulations for topicaladministration. The cellulite treatment formulations can be filled intosuitable packaging (containers) such as, for example, tubes, cartons,capsule, jars, bottles, canisters, squeeze pack, pouches, packages,packets, sacks, tank, or other containers. In some embodiments, thecellulite treatment formulation may be applied directly to skin havingor manifesting cellulite. In some embodiments, the cellulite treatmentformulation may be applied an applicator, a brush, or other device forapplication to the skin having or manifesting cellulite.

In some embodiments, the cellulite treatment formulation is applieddirectly to an area of the subject's skin, for example, a region of skinaffected by cellulite, or predisposed to develop cellulite. In otherembodiments, the cellulite treatment formulation is applied directly tothe area affected by cellulite or predisposed to develop cellulite byone or more of a dropper, an applicator stick, as a mist or aerosol, asa transdermal patch, by wiping with a wipe, or by spreading thecellulite treatment formulation on the area with fingers. The cellulitetreatment formulation can be applied to the cellulite-affected area inany suitable therapeutic amount. In some embodiments, the cellulitetreatment formulation is administered and/or applied to thecellulite-affected area in ounce units such as from 0.1 oz. to 20 oz. oras desired by the subject. Each application to the cellulite-affectedarea can be about 0.1 oz., 0.2 oz., 0.3 oz., 0.4 oz., 0.5 oz., 0.6 oz.,0.7 oz., 0.8 oz., 0.9 oz., 1 oz., about 2 oz., about 3 oz., about 4 oz.,about 5 oz., about 6 oz., about 7 oz., about 8 oz., about 9 oz., about10 oz., about 11 oz., about 12 oz., about 16 oz., or about 20 oz. Whenapplied to the cellulite-affected area, it can be applied once, twice,three times, four times or more a day. In one embodiment, the cellulitetreatment formulation is applied to the cellulite-affected area at arate of about 4 oz. twice a day. Likewise, the cellulite treatmentformulation can be applied to areas of the subject's skin to prevent theformation of cellulite in similar fashion to the administration to treatcellulite.

Packaging can include single use aliquots in single use packaging suchas pouches. The cellulite treatment formulation can be packaged insuitable packaging having volumes of about 0.1 oz., about 0.2 oz., about0.5 oz., about 1 oz., about 2 oz., about 4 oz., about 8 oz., about 16oz., about 32 oz., about 48 oz., about 64 oz., about 80 oz., about 96oz., about 112 oz., about 128 oz., about 144 oz., about 160 oz., or anamount within a range defined by any two of the aforementioned values.The packaging can also be squeezable pouches having similar volumes.

In some embodiments, packaging may be free of dyes, metal specks, orchemicals that can be dissolved by acids or oxidizing agents. In otherembodiments, any bottles, package caps, bottling filters, valves, lines,and heads used in packaging may be specifically rated for acids andoxidizing agents. In some cases, package caps with any organic glues,seals, or other components sensitive to oxidation may be avoided sincethey could neutralize and weaken the product over time.

As used herein, the term “coadministration” of pharmacologically activecompounds refers to the delivery of two or more separate chemicalentities or separate therapies, whether in vitro or in vivo.Coadministration refers to the simultaneous delivery of separate agentsor therapies; to the simultaneous delivery of a mixture of agents; tothe delivery of one agent followed by delivery of a second agent oradditional agents; or to the administration of one therapy followed byor concomitant with another therapy. In all cases, agents or therapiesthat are coadministered are intended to work in conjunction with eachother. Similarly, in the context of administration of more than onecompound, the term “in combination” refers to a concomitant delivery ofone compound with one or more compounds. The compounds may beadministered in combination by simultaneous administration oradministration of one compound before or after administration of anothercompound.

In some embodiments, the cellulite treatment formulation for treating acellulite as described herein is administered alone, in the absence ofother treatments, therapies, or agents for the treatment of cellulite.In some embodiments, the cellulite treatment formulation for treatingcellulite as described herein administered in combination with acellulite therapy, including laser therapy, shockwave therapy,ultrasound therapy, cellulite creams, scrubs, brushes, massage,mesotherapy, liposuction, or subcision, or other therapy used for thetreatment of cellulite.

In some embodiments, the cellulite treatment formulation provided hereinis used in combination with laser therapy. As used herein, laser therapyincludes the use of optical energy, such as a diode laser or solid-statelaser to target an area affected with cellulite. In some embodiments,the laser therapy includes cellulaze. As used herein, cellulaze includesinsertion of a laser tube under the skin of the subject in an areaaffected with cellulite, and is used to melt the pockets of fat, andsoften the connective tissue.

In some embodiments, the cellulite treatment formulation provided hereinis used in combination with shockwave therapy. As used herein, shockwavetherapy refers to a non-surgical, non-invasive treatment usinghigh-frequency acoustic shockwaves, which focus on the collagenstructure of cellulite-affected skin, causing a remodeling of thecollagen fibers. Shockwave therapy can include focused shockwave, shortfocused shockwave, long focused shockwave, unfocused shockwave, linearunfocused shockwave, or radial unfocused shockwave.

In some embodiments, the cellulite treatment formulation provided hereinis used in combination with ultrasound therapy. As used herein,ultrasound therapy includes cryolipolysis, a non-invasive method forlocalized destruction of subcutaneous adipocytes.

In some embodiments, the cellulite treatment formulation provided hereinis administered in combination with an anti-cellulite product, such as acream or other composition used in the treatment of cellulite. In someembodiments, the cellulite treatment formulation as provided herein isadministered prior to application of the cream or other composition. Insome embodiments, the cream or other composition is administered priorto administration of the cellulite treatment formulation.

In some embodiments, the cellulite treatment formulation provided hereinis administered in combination with a cellulite scrub. As used herein, acellulite scrub refers to a cleansing of the skin affected withcellulite with an exfoliating body scrub or an exfoliating brush used tosmooth the skin to improve the appearance of cellulite.

In some embodiments, the cellulite treatment formulation provided hereinis administered in combination with a cellulite massage. As used hereina cellulite massage refers to a massage technique to increasecirculation and to improve the appearance of cellulite. Massage caninclude mechanical devices, or pressotherapy, such as endermologie,subdermal massage, rolling massage, suction massage, or other types ofmassage, and can be used in combination with the cellulite treatmentformulations described herein.

In some embodiments, the cellulite treatment formulation is used incombination with mesotherapy. As used herein mesotherapy refers to atherapy that includes injection of various treatment solutions throughthe skin to treat cellulite. The injection results in increasedcirculation and the potential for fat oxidation, and includes injectionof compounds such as aminophylline, hyaluronic acid, Novocain, plantextracts, vitamins, antifibrotics, lypolytics, or anti-inflammatories.

In some embodiments, the cellulite treatment formulation is used incombination with liposuction, tumescent liposuction, or lipolysis, whichtarget adipose tissue in the subdermal and deep fat regions of the body.These techniques may include removing the fat cells once they aredisrupted, or leaving them to be resorbed by the body's immune/lymphaticsystem. Traditional liposuction includes the use of a surgical cannulaplaced at the site of the fat to be removed, and then the use of aninfusion of fluids and mechanical motion of the cannula to break up thefatty tissue, and suction to “vacuum” the disrupted fatty tissuedirectly out of the patient.

In some embodiments, the cellulite treatment formulation is used incombination with subcision. This technique involves the insertion of arelatively large gauge needle subdermally in the region of dimpling orscarring, and then mechanically manipulating the needle below the skinto break up the fibrous septae in the subdermal region.

In some embodiments, the “purity” of any given agent (for example,hypochlorous acid or a buffer) in a composition may be specificallydefined. For instance, certain compositions may include, for example, anagent that is at least 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99,or 100% pure, including all decimals in between, as measured, forexample and by no means limiting, by analytical chemistry techniques.

In some embodiments, the cellulite treatment formulation may be applieddirectly into the skin, and therefore, the cellulite treatmentformulation may be formulated for topical application. Accordingly, thecellulite treatment formulation may have any suitable form for topicaladministration. In some embodiments the formulation is in the form of acream, a hydrogel, a lotion, a gel, a serum, a liquid, a foam, a mist,or an ointment. In some embodiments, the cellulite treatment formulationmay be applied by injection into an area of the body having ormanifesting cellulite, such as by intradermal or subcutaneousadministration.

The cellulite treatment formulations described herein are used for thetreatment, prevention, amelioration, or reduction of cellulite or themanifestation of cellulite. In some embodiments, the formulation isadministered by topically applying a therapeutic amount of theformulations to areas of the skin that are affected by cellulite. Inother embodiments, the formulation is administered by topically applyinga therapeutic amount of the formulations to areas of the skin that areaffected by adiposis edematosa, dermopanniculosis deformans, statusprotrusus cutis, gynoid lipodystrophy, and/or orange peel syndrome. Inother embodiments, the formulation is administered by topically applyinga therapeutic amount of the formulations to areas of the skin to preventthe formation of cellulite. For example, the formulation can be appliedto areas of the skin that are affected by cellulite such as the pelvicregion, lower limbs, abdomen, buttocks, and/or thighs. In some cases,the formulation can be applied to areas of the skin to prevent theformation of cellulite such as the pelvic region, lower limbs, abdomen,buttocks, and/or thighs. The pelvic region, lower limbs, abdomen,buttocks, and/or thighs are predisposed to the development of cellulite.The formulation may be applied to these regions to treat cellulite, toreduce the manifestation of cellulite, or to prevent the development ofcellulite.

In some embodiments, the cellulite treatment formulations areadministered to a subject by topical application of the formulation to aregion of the body affected by cellulite, or a region of the body wherethe prevention of cellulite is desirable. In some embodiments, thecellulite treatment formulation is administered by massaging theformulations into the region of the body until the formulation isabsorbed.

In some embodiments, administration of the cellulite treatmentformulation increases skin elasticity, reduces the appearance ofcellulite, reduces fat nodules, reduces subcutaneous fat nodularity,inhibits adipogenesis, or increases lipolysis in adipocytes.

In some embodiments, treating cellulite comprises applying theformulation to skin affected by cellulite to increase elasticity of theskin at the treated area. In some cases, the elasticity of an area ofcellulite-affected skin can be measured before treatment. The affectedarea can then be treated and the elasticity of the treated area can bemeasured. In other cases, the treated area can exhibit an increase inelasticity. In some instances, the increase in elasticity of the treatedarea can be up to about 1%, about 2%, about 3%, about 4%, about 5%,about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%,about 25%, about 30%, about 35%, and about 40%. In other instances, theincrease in elasticity may be seen after 1 day to 1 year, such as after1 day, after 2 days, after 3 days, after 4 days, after 5 days, after 6days, after 1 week, after 2 weeks, after 3 weeks, after 4 weeks, after 1month, after 2 months, after 3 months, after 4 months, after 5 months,after 6 months, after 7 months, after 8 months, after 9 months, after 10months, after 11 months, or after 1 year.

In some embodiments, reducing the appearance of cellulite includesreducing the severity of cellulite based on the manifestation ofcellulite, such that the manifestation of cellulite decreases from hardsub-surface nodules and pronounced lumpiness of the skin and striations,to small bumps or depressions, and no cellulite present. The reducedappearance of cellulite can be assessed by measuring the appearance ofthe skin at the treated region, the reduction of thigh diameter, thereduction of the fatty layer thickness, skin firmness, surfacesmoothness,

The disclosure is generally described herein using affirmative languageto describe the numerous embodiments. The disclosure also includesembodiments in which subject matter is excluded, in full or in part,such as substances or materials, method steps and conditions, protocols,or procedures.

EXAMPLES

Some aspects of the embodiments discussed above are disclosed in furtherdetail in the following examples, which are not in any way intended tolimit the scope of the present disclosure. Those in the art willappreciate that many other embodiments also fall within the scope of thedisclosure, as it is described herein above and in the claims.

Example 1 Preparation of Cellulite Treatment Formulations

The following example describes an embodiment of a cellulite treatmentformulation and methods of making the formulation.

A cellulite treatment formulation was prepared with the ingredients asprovided in Table 1. The ingredients provided below were added to salinesolution, with a final pH adjusted to 6.5-7.0. The saline solution wasprepared with 0.05% salt.

TABLE 1 Cellulite Treatment Formulation Ingredient Final % wt/vol Rolein Formulation Saline Solution (0.05% salt) 91.378 Base Laponite XLG3.25 Rheology agent Dimethicone Satin 5 Emollient Sodium Hypochlorite(4.99%) 0.072 Reactive oxygen species Sodium Phosphate Monobasic 0.3 pHmodifier

Refined salts, such as tables salts can be used to prepare the salinesolution, which include the components listed in Table 2.

TABLE 2 Refined salt components used in saline solution Element Quantity(ppm) Aluminum 0.747 Antimony 0.014 Arsenic 0.039 Barium 0.012 Beryllium0.038 Bismuth 0.005 Bromide 81.414 Cadmium 0.007 Calcium 10.625 Chromium0.027 Cobalt 0.001 Copper 0.053 Germanium 0.081 Iodide <0.001 Iron 0.639Lead 25.908 Magnesium 3.753 Manganese 0.040 Mercury 0.013 Molybdenum0.007 Nickel 0.016 Phosphorus 3.690 Potassium 60.756 Selenium 0.202Silver 0.002 Sodium 391,290 Strontium 0.230 Tin 0.166 Zinc 0.791

The salt composition of Table 2 is refined table salt, and the quantityof elements was determined by inductively couple plasma massspectrometry (ICP-MS). Teachings in the art suggest that only purified,refined salts may be used in a saline solution having reactive oxygenspecies, such as hypochlorite, and that raw or unprocessed salts areincompatible for use in a saline solution having reactive oxygenspecies. Thus, not only can raw, unprocessed salts be used in the salinesolution, but raw, unprocessed salts result in raw salt compositionsthat function unexpectedly superior to compositions prepared usingrefined salts. The components for the raw salt composition using rawsalt are provided in Table 3, in three separate salt compositions.

TABLE 3 Raw salt components used in saline solution Composition 1Composition 2 Composition 3 Element Quantity (ppm) Aluminum 114.8 32.473241.700 Antimony 0.022 0.013 0.026 Arsenic 0.066 0.046 0.076 Barium0.664 0.343 7.615 Beryllium 0.051 0.030 0.070 Bismuth 0.005 0.004 0.006Bromide 56.006 70.607 7.789 Cadmium 0.017 0.010 0.024 Calcium 2101.0001290.000 1860.000 Chromium 0.207 0.195 0.175 Cobalt 0.033 0.013 0.058Copper 0.116 0.090 0.279 Germanium 0.072 0.085 0.092 Iodide <0.001<0.001 <0.001 Iron 81.722 23.292 141.400 Lead 0.093 0.077 0.210Magnesium 1944.000 1304.000 217.900 Manganese 1.911 1.040 11.804 Mercury0.016 0.009 0.012 Molybdenum 0.011 0.014 0.037 Nickel 0.096 0.086 0.113Phosphorus 5.125 3.548 9.541 Potassium 1728.000 1174.000 149.300Selenium 0.269 0.235 0.226 Silver 0.004 0.002 0.006 Sodium 388690.000391706.000 390600.000 Strontium 32.223 18.328 11.251 Tin 0.169 0.1350.177 Zinc 1.261 1.045 1.883

The raw salt compositions provided in Table 3 were analyzed by ICP-MS todetermine the quantity of elements. The salt compositions used werevarious types of raw sea salt (compositions 1 and 2—Himalayan pink seasalt; composition 3—sea salt).

The cellulite treatment formulation described in Table 1 is useful forthe treatment, prevention, amelioration, or reduction of cellulite orthe manifestation of cellulite, especially when the saline solution isprepared using a salt provided in Table 3, or other forms of raw saltdescribed herein. The formulation may be used alone in or in combinationwith cellulite treatment therapies. Furthermore, the formulation may beapplied directly to the region affected by cellulite or may be appliedwith a device, such as an applicator. In some embodiments, theformulation may be prepared as a gel, a cream, a salve, a serum, a foam,a paste, a lotion, an ointment, or other composition suitable fortopical administration to the skin. In some embodiments, the formulationmay be prepared for injection, such as by intradermal or subcutaneousadministration to a region of skin affected by cellulite.

Example 2 Additional Cellulite Treatment Formulations

The following example describes an embodiment of a cellulite treatmentformulation.

A cellulite treatment formulation including salts in variety wasprepared with the ingredients as provided in Table 4. The ingredientsprovided below were added to water, with a final pH adjusted to 6.5-7.0.

TABLE 4 Salt Cellulite Treatment Formulation Ingredient Final % wt/wtWater 95.53% Salt  0.05% Metal Silicate  3.14% Silicon Polymer  0.93%Reactive Oxygen Species  0.16% pH Modifier  0.19%

The salt cellulite composition in Table 4 included a salt of halite,table salt, common salt, curing salt, flake salt, Epsom salt, sea salt,Alaea salt (or Hawaiian sea salt), Alpenbergkern salt, Anglesey Seasalt, Celtic sea salt, Dead Sea salt, Himalayan sea salt (includingHimalayan pink sea salt), Kalahari salt, Maras salt, Murray River saltflakes, Namibian salt pearls, Persian blue fine salt, Polish mine salt,primordial sea salts, Sal de Tavira, Sale Marino di Trapani, Sel deGuérande, South African Sea salt, Utah salt, black lava salt, brine,rock salt, red rock salt, fleur de sel, or kosher salt, or combinationsthereof.

The cellulite treatment formulation described in Table 4 is useful forthe treatment, prevention, amelioration, or reduction of cellulite orthe manifestation of cellulite. The formulation may be used alone in orin combination with cellulite treatment therapies. Furthermore, theformulation may be applied directly to the region affected by celluliteor may be applied with a device, such as an applicator. In someembodiments, the formulation may be prepared as a gel, a cream, a salve,a serum, a foam, a paste, a lotion, an ointment, or other compositionsuitable for topical administration to the skin. In some embodiments,the formulation may be prepared for injection, such as by intradermal orsubcutaneous administration to a region of skin affected by cellulite.

Example 3 Cellulite Treatment Formulations for Reducing Cellulite

The following example describes the use of the cellulite treatmentformulations provided herein to treat, prevent, and reduce cellulite orthe appearance of cellulite.

The cellulite treatment formulation as described in Examples 1 or 2 isused to treat, prevent, reduce, or ameliorate cellulite or theappearance of cellulite.

Female subjects are selected to evaluate the formulation. Subjects areselected based on their cellulite intensity in a region affected withcellulite. A 5-point grading scale is used to rate the celluliteseverity of each subject prior to administration of the cellulitetreatment formulation. The scale ranges from 0 to 4, being 0=Nocellulite; 1=Small bumps or depressions; 2=Striations and bumps;3=Pronounced lumpiness of the skin and striations; 4=All of the aboveplus hard sub-surface nodules.

All subjects have the absence of any visible skin diseases that might beconfused with a skin reaction from the test material and are in generalgood health with no known allergies, especially to cosmetic or toiletryproducts; have no evidence of acute or chronic disease; are not pregnantor lactating; are not on any diet or weight reduction program; and arenot on any regular exercise program (immediately prior to or during thecourse of the study).

At baseline each subject receives a visual examination conducted by aqualified technician and receives a score for the degree of cellulite.On the same day, subjects are administered a cellulite treatmentformulation. The treatment is repeated daily over the course of thestudy. All subjects tolerate the topical formulation during the courseof the study as measured by dermatological and clinical criteria. Foreach volunteer, a test area (treated area) and a control area (untreatedarea) are selected on the cellulite-affected area of the skin. Thetopical formulation is applied daily to the test area. The topicalformulation is not applied to the control area. There are no undesiredor pathological skin reactions in the test area. The subjects are alsodivided into appropriate control groups to test the efficacy of thecellulite treatment formulations against control formulations, includingrefined salt formulations (as described herein) or no treatment.

The degree of cellulite is observed by digital photography of the testskin area, and evaluations are given according to the following scale:0=No visible cellulite; 1=Very little visible cellulite, no dimpling;2=Visible cellulite, evidence of shallow dimpling; 3=Easily visiblecellulite, moderate to pronounced dimpling; 4=Extremely visiblecellulite, heavy and deep dimpling. In addition, the following data arecollected at the beginning of the study and after the study: cutometry(skin elasticity) measurements of the test area; ultrasound examinationof the test skin area; and depth and width measurements of the adiposelobules. Each subject also completes a participant questionnairefollowing completion of the study.

Subjects are instructed to discontinue the use of their normalanti-cellulite products or therapies, to avoid introducing any newproducts for treating cellulite during the study, and to not be on anydiet or weight reduction program or on any regular exercise programimmediately prior to or during the course of the study.

Following the final treatment, subjects return for a final visualevaluation. The cellulite evaluation is made by comparison of the valuesbefore and after the treatment with the cellulite treatmentformulations. The efficacy of the cellulite treatment formulations isevaluated based on skin firmness, reduction of thigh diameter, reductionof fatty layer thickness, skin hydration, surface smoothness, andreduction in the appearance of cellulite.

Example 4 Comparative Cellulite Treatment Formulations

The following example compares the cellulite treatment formulationdescribed in Example 1 with refined salt cellulite treatmentformulations. A comparison of the formulations is provided in Table 5.

TABLE 5 Comparative Cellulite Treatment Formulations Final % wt/volFinal % wt/vol of Example 1 of refined salt Ingredient FormulationFormulation Saline Solution 91.378 (0.05% raw 96.51 (0.07% refined saltcomponents salt components of Table 3) of Table 2) Laponite XLG 3.253.25 Dimethicone Satin 5 — Sodium Hypochlorite (4.99%) 0.072 0.040Sodium Phosphate Monobasic 0.3 0.2

The cellulite treatment formulations as described in Table 5 arecompared for efficacy in treating, preventing, reducing, or amelioratingcellulite or the appearance of cellulite. Subjects are administered acomposition, as described in Example 3. The subjects are divided intogroups, including a no treatment group, a group administered theformulation of Example 1 or Example 2, and a group administered arefined salt formulation. The formulation of Example 1 or Example 2,which includes raw salt components, unexpectedly exhibits superiortreatment properties in comparison to the refined salt formulation.Subjects administered the formulation of Example 1 or Example 2 exhibitsuperior improvements in the appearance of cellulite as compared tosubjects that received the refined salt formulation and in comparison tosubjects that received no treatment.

In at least some of the previously described embodiments, one or moreelements used in an embodiment can interchangeably be used in anotherembodiment unless such a replacement is not technically feasible. Itwill be appreciated by those skilled in the art that various otheromissions, additions and modifications may be made to the methods andstructures described above without departing from the scope of theclaimed subject matter. All such modifications and changes are intendedto fall within the scope of the subject matter, as defined by theappended claims.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” etc.). It will be further understood by those withinthe art that if a specific number of an introduced claim recitation isintended, such an intent will be explicitly recited in the claim, and inthe absence of such recitation no such intent is present. For example,as an aid to understanding, the following appended claims may containusage of the introductory phrases “at least one” and “one or more” tointroduce claim recitations. However, the use of such phrases should notbe construed to imply that the introduction of a claim recitation by theindefinite articles “a” or “an” limits any particular claim containingsuch introduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (for example, “a” and/or “an” should be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould be interpreted to mean at least the recited number (for example,the bare recitation of “two recitations,” without other modifiers, meansat least two recitations, or two or more recitations). Furthermore, inthose instances where a convention analogous to “at least one of A, B,and C, etc.” is used, in general such a construction is intended in thesense one having skill in the art would understand the convention (forexample, “a system having at least one of A, B, and C” would include butnot be limited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (for example, “a system having at least one of A, B, orC” would include but not be limited to systems that have A alone, Balone, C alone, A and B together, A and C together, B and C together,and/or A, B, and C together, etc.). It will be further understood bythose within the art that virtually any disjunctive word and/or phrasepresenting two or more alternative terms, whether in the description orclaims, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms. Forexample, the phrase “A or B” will be understood to include thepossibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible sub-rangesand combinations of sub-ranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, etc. As a non-limiting example, each range discussed herein canbe readily broken down into a lower third, middle third and upper third,etc. As will also be understood by one skilled in the art all languagesuch as “up to,” “at least,” “greater than,” “less than,” and the likeinclude the number recited and refer to ranges which can be subsequentlybroken down into sub-ranges as discussed above. Finally, as will beunderstood by one skilled in the art, a range includes each individualmember. Thus, for example, a group having 1-3 articles refers to groupshaving 1, 2, or 3 articles. Similarly, a group having 1-5 articlesrefers to groups having 1, 2, 3, 4, or 5 articles, and so forth.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A cellulite treatment formulation, comprising: anelectrolyzed saline solution comprising a salt; a reactive oxygenspecies comprising hypochlorite; a rheology agent; an emollient; and apH modifier.
 2. The cellulite treatment formulation of claim 1, whereinthe salt is present in an amount of about 0.01% to about 1% w/v.
 3. Thecellulite treatment formulation of claim 1, wherein the salt is presentin an amount of about 0.05% w/v.
 4. The cellulite treatment formulationof claim 1, wherein the salt is raw, unprocessed salt.
 5. The cellulitetreatment formulation of claim 1, wherein the salt is Himalayan seasalt.
 6. The cellulite treatment formulation of claim 1, wherein thehypochlorite is present in an amount of about 25 to about 100 ppm. 7.The cellulite treatment formulation of claim 1, wherein the hypochloriteis present in an amount of about 72 ppm.
 8. The cellulite treatmentformulation of claim 1, wherein the rheology agent is a metal silicate.9. The cellulite treatment formulation of claim 1, wherein the rheologyagent is sodium magnesium silicate present in an amount of about 0.5% toabout 10% w/v.
 10. The cellulite treatment formulation of claim 1,wherein the emollient is dimethicone, cyclomethicone, or a blend thereofpresent in an amount of about 0.5% to about 10% w/v.
 11. The cellulitetreatment formulation of claim 1, wherein the pH modifier is sodiumphosphate monobasic present in an amount of about 0.05% to about 5% w/v.12. The cellulite treatment formulation of claim 1, wherein theformulation is in the form of a cream, foam, gel, serum, lotion, mousse,ointment, paste, serum, solution, spray, stick, or suspension.
 13. Thecellulite treatment formulation of claim 1, wherein the formulation hasan osmolality measurement ranging from about 3 to about 5 mOsm/kg. 14.The cellulite treatment formulation of claim 1, wherein the formulationcomprises: salt in an amount of about 0.01% to about 1% w/v;hypochlorite in an amount of about 60 to about 80 ppm; sodium magnesiumsilicate in an amount of about 0.5% to about 10% w/v; dimethicone in anamount of about 0.5% to about 10% w/v; and sodium phosphate monobasic inan amount of about 0.05% to about 5% w/v.
 15. The cellulite treatmentformulation of claim 1, wherein the salt comprises: aluminum in anamount ranging from 32 to 241 ppm; calcium in an amount ranging from1290 to 2101 ppm; iron in an amount ranging from 23 to 141 ppm;magnesium in an amount ranging from 217 to 1944 ppm; and potassium in anamount ranging from 149 to 1174 ppm.
 16. A method of reducing anappearance of cellulite in a subject in need thereof, the methodcomprising: identifying a region of a body having cellulite; andtopically applying to the region of the body a composition comprising:an electrolyzed saline solution comprising raw salt; hypochlorite; arheology agent; an emollient; and a pH modifier; thereby reducing theappearance of cellulite,
 17. The method of claim 16, wherein the rawsalt is Himalayan sea salt and the hypochlorite is present in an amountof 0.0025 to 0.01% w/v in the composition.
 18. The method of claim 16,further comprising massaging the composition into the region of the bodyhaving cellulite until absorbed.
 19. The method of claim 16, wherein thecomposition is administered daily to the region of the body havingcellulite.
 20. The method of claim 16, wherein reducing the appearanceof cellulite comprises increasing skin elasticity, reducing subcutaneousfat nodularity, or increasing lipolysis in adipocytes.